- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00545272
A Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via TWISTHALER® Device in Adult and Adolescent Patients With Persistent Asthma
December 12, 2012 updated by: Novartis Pharmaceuticals
A Randomized, Multi-center, Parallel Group, Double Blind, Placebo and Formoterol Controlled 14 Day Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via TWISTHALER® Device in Adult and Adolescent Patients With Persistent Asthma
This study will evaluate the dose response relationship among four doses of indacaterol as well as placebo delivered via the TWISTHALER® device.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
392
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aalst, Belgium
- Novartis Investigator Site
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Halen, Belgium
- Novartis Investigator Site
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Oostham, Belgium
- Novartis Investigator Site
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Veurne, Belgium
- Novartis Investigator Site
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Boskovice, Czech Republic
- Novartis Investigator Site
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Breclav, Czech Republic
- Novartis Investigator Site
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Brno, Czech Republic
- Novartis Investigator Site
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Liberec, Czech Republic
- Novartis Investigator Site
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Most, Czech Republic
- Novartis Investigator Site
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Tabor, Czech Republic
- Novartis Investigator Site
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Aalen, Germany
- Novartis Investigator Site
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Berlin, Germany
- Novartis Investigator Site
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Braunschweig, Germany
- Novartis Investigator Site
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Deggendorf, Germany
- Novartis Investigator Site
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Furstenwalde, Germany
- Novartis Investigator Site
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Leipzig, Germany
- Novartis Investigator Site
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Munchen, Germany
- Novartis Investigator Site
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Balassagyarmat, Hungary
- Novartis Investigator Site
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Erd, Hungary
- Novartis Investigator Site
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Fuzesabony, Hungary
- Novartis Investigator Site
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Gyonggyos, Hungary
- Novartis Investigator Site
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Mosdoz, Hungary
- Novartis Investigator Site
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Pest, Hungary
- Novartis Investigator Site
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Siofok, Hungary
- Novartis Investigator Site
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Szazhalombatta, Hungary
- Novartis Investigator Site
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Afula, Israel
- Novartis Investigator Site
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Ashkelon, Israel
- Novartis Investigator Site
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Beer Sheva, Israel
- Novartis Investigator Site
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Haifa, Israel
- Novartis Investigator Site
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Jerusalem, Israel
- Novartis Investigator Site
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Petach Tikva, Israel
- Novartis Investigator Site
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Rehovot, Israel
- Novartis Investigator Site
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Tel Aviv, Israel
- Novartis Investigator Site
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Tel-Hashorner, Israel
- Novartis Investigator Site
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Zrifin, Israel
- Novartis Investigator Site
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Bialystok, Poland
- Novartis Investigator Site
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Bydgoszcz, Poland
- Novartis Investigator Site
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Lodz, Poland
- Novartis Investigator Site
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Lubin, Poland
- Novartis Investigator Site
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Tarnow, Poland
- Novartis Investigator Site
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Moscow, Russian Federation
- Novartis Investigator Site
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Saint-Petersburg, Russian Federation
- Novartis Investigator Site
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Smolensk, Russian Federation
- Novartis Investigator Site
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Tomsk, Russian Federation
- Novartis Investigator Site
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Bloernfontain, South Africa
- Novartis Investigator Site
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Cape Town, South Africa
- Novartis Investigator Site
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Johannesburg, South Africa
- Novartis Investigator Site
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Krugersdorp, South Africa
- Novartis Investigator Site
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Pretoria, South Africa
- Novartis Investigator Site
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Roodepoort, South Africa
- Novartis Investigator Site
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Temba, South Africa
- Novartis Investigator Site
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les Marais, South Africa
- Novartis Investigator Site
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Madrid, Spain
- Novartis Investigator Site
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Pozuelo de Alacron, Spain
- Novartis Investigator Site
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Valencia, Spain
- Novartis Investigator Site
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Downpatrick, United Kingdom
- Novartis Investigator Site
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Glasgow, United Kingdom
- Novartis Investigator Site
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London, United Kingdom
- Novartis Investigator Site
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Southampton, United Kingdom
- Novartis Investigator Site
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Watford, United Kingdom
- Novartis Investigator Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male and female adult and adolescent patients aged 12-75 years inclusive (or ≥18-75 years depending upon regulatory and/or Institutional Review Board (IRB)/Independent Ethics Committee (IEC)/Research Ethics Board (REB) approval), who have signed an Informed Consent Form prior to initiation of any study-related procedure, including any adjustments to asthma medication prior to Visit 1. Patients below the legal age of consent are required to have the Informed Consent Form signed by the patient's parent / guardian.
Patients with asthma, diagnosed according to Global Initiative for Asthma (GINA) guidelines (National Institute of Health, National Heart, Lung and Blood Institute, 2006) and who additionally meet the following criteria:
- Patients receiving daily treatment with inhaled corticosteroid up to the maximum dose per day indicated in the package leaflet, in a stable regimen for the month prior to Visit 1.
- Patients with a Forced Expiratory Volume in one second (FEV1) at Visit 1 of ≥50% of the predicted normal value for the patient. This criterion for FEV1 will have to be demonstrated after a washout period of at least 6 hours during which no short acting β2-agonist has been inhaled, and a minimum of 48 hours for a long acting β2-agonist.
- Patients who demonstrate an increase of ≥12% and ≥200 mL in FEV1 over their pre-bronchodilator value within 30 minutes after inhaling a total of 200 µg/180 µg of salbutamol/albuterol Metered Dose Inhaler (MDI) (or equivalent dose of Dry Powder Inhaler [DPI]) (the reversibility test). Reversibility will have to be demonstrated after an appropriate washout period of at least 6 hrs prior to the evaluation for a short-acting β2-agonist. The administration of salbutamol/albuterol for the reversibility test is to be within 30 minutes after pre bronchodilator spirometry. Reversibility has to be demonstrated at Visit 1 or between Visits 1 and 2, in order for patients to be included in the trial.
Exclusion Criteria:
- Pregnant women, nursing mothers, or females of childbearing potential, regardless of whether or not sexually active, if they are not using a reliable form of contraception.
- Patients with Chronic Obstructive Pulmonary Disease (COPD), or current smokers, or patients who have used tobacco products within the 6 month period prior to Visit 1, or who have a smoking history of greater than 10 pack years.
Patients:
- who's asthma is likely to deteriorate during the study (including seasonal allergy),
- hospitalized for an acute asthma attack/asthma exacerbation within 6 months prior to Visit 1,
- who have had an emergency room visit for an asthma attack/asthma exacerbation within 6 weeks prior to Visit 1
- who have had a respiratory tract infection or emergency room treatment for an asthma attack/asthma exacerbation within 4 weeks prior to Visit 1
- Patients who require the use of ≥8 inhalations per day of short acting B2-agonist (100 µg/ 90 µg salbutamol/albuterol MDI or equivalent dose of DPI) on any 2 consecutive days from Screening to Randomization.
Other protocol-defined inclusion/exclusion criteria may apply
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: indacaterol 62.5 μg
Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.
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Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).
Placebo AEROLIZER® device
100 μg/ 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).
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Experimental: indacaterol 125 μg
Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.
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Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).
Placebo AEROLIZER® device
100 μg/ 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).
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Experimental: indacaterol 500 μg
Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.
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Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).
Placebo AEROLIZER® device
100 μg/ 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).
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Active Comparator: formoterol
Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.
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Formoterol delivered by oral inhalation via AEROLIZER® inhalation device.
Placebo TWISTHALER® device
100 μg/ 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).
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Placebo Comparator: placebo
Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.
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Placebo AEROLIZER® device
Placebo TWISTHALER® device
100 μg/ 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).
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Experimental: indacaterol 250 μg
Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.
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Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).
Placebo AEROLIZER® device
100 μg/ 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: Baseline (prior to first dose) and Day 15 (24 hours after last dose)
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FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.
Change from baseline to 24 hour post dose trough FEV1 after 14 days of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate.
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Baseline (prior to first dose) and Day 15 (24 hours after last dose)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) on Day 1
Time Frame: Day 1 Baseline (prior to first dose) and 24 hours post-dose.
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FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.
Change from baseline to 24 hour post dose trough FEV1 after 1 day of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate.
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Day 1 Baseline (prior to first dose) and 24 hours post-dose.
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Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 14
Time Frame: Day 1 and Day 14 measured pre-dose and up to 4 hours post-dose
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FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.
Time to peak FEV1 is calculated in minutes from the time of inhalation of study drug to the time of the peak FEV1, which is taken as the maximum FEV1 recorded post-dose.
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Day 1 and Day 14 measured pre-dose and up to 4 hours post-dose
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Number of Participants Using Rescue Medication
Time Frame: Over 14 days
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Participants recorded the use of rescue medications (salbutamol/albuterol) for treatment of asthma symptoms twice a day in a diary during the 14 days of the treatment period.
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Over 14 days
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Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose
Time Frame: Day 14, pre-dose, 5, 20 and 30 minutes, 1, 2, 3, and 4 hours post-dose.
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FEV1 was measured on Day 14 pre-dose and up to 4 hours post-dose.
The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate.
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Day 14, pre-dose, 5, 20 and 30 minutes, 1, 2, 3, and 4 hours post-dose.
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Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose on Day 1
Time Frame: Day 1, pre-dose, 5, 20 and 30 minutes, 1, 2, 3, and 4 hours post-dose.
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FEV1 was measured on Day 1 pre-dose and up to 4 hours post-dose.
The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate.
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Day 1, pre-dose, 5, 20 and 30 minutes, 1, 2, 3, and 4 hours post-dose.
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Change From Baseline in Morning and Evening Peak Expiratory Flow
Time Frame: Baseline (recorded during the screening period) and Days 1-14 (treatment period)
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The Peak Expiratory Flow (PEF) rate is the maximal rate that a person can exhale during a short maximal expiratory effort after fully inhaling.
Participants measured their PEF using a peak flow meter and recorded measurements in a diary every morning and evening during the study, prior to taking study medication.
Change from baseline is the difference between the mean baseline PEF recorded during the screening period until the first day of treatment, and the overall mean PEF from Days 1 to 14.
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Baseline (recorded during the screening period) and Days 1-14 (treatment period)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
April 1, 2008
Study Completion (Actual)
April 1, 2008
Study Registration Dates
First Submitted
October 16, 2007
First Submitted That Met QC Criteria
October 16, 2007
First Posted (Estimate)
October 17, 2007
Study Record Updates
Last Update Posted (Estimate)
January 18, 2013
Last Update Submitted That Met QC Criteria
December 12, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Formoterol Fumarate
Other Study ID Numbers
- CQMF149A2201
- 2007-003191-19 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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